Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
Pilot Study of Redirected Autologous T Cells Transduced to Express A CD20-Specific Chimeric Immunoreceptor in Patient With Chemotherapy Resistant or Refractory CD20+ Leukemia and Lymphoma
RATIONALE: Placing a gene that has been created in the laboratory into white blood cells may
make the body build an immune response to kill cancer cells.
PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in
treating patients with B-cell leukemia or lymphoma that is resistant or refractory to
chemotherapy.
PRIMARY OBJECTIVES:
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced
with the anti-CD20 vector (referred to as CART-20 cells).
II. Determine duration of in vivo survival of CART-20 cells. RT-PCR analysis of whole blood
will be used to detect and quantify survival of CART-20 TCR zeta:4-1BB over time.
SECONDARY OBJECTIVES:
I. For patients with detectable disease, measure anti-tumor response due to CART-20 cell
infusions.
II. Estimate relative trafficking of CART-20 cells to tumor in bone marrow and lymph nodes.
III. For patients with stored or accessible tumor cells (such as patients with active CLL,
ALL, etc) determine tumor cell killing by CART-20 cells in vitro.
IV. Determine if cellular or humoral host immunity develops against the murine anti-CD20,
and assess correlation with loss of detectable CART-20 (loss of engraftment).
V. Determine the relative subsets of CART-20 T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned groups according to order of enrollment.
Patients receive anti-CD20-CAR lentivirus vector-transduced autologous T cells with
41BB-gamma vector for 3-5 days in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3
months for 2 years, and annually thereafter for 13 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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